JERUSALEM & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Dec. 8, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle
Pharmaceuticals, Inc. (Nasdaq:EGRX) today announce that the U.S. Food
and Drug Administration (FDA) has approved BENDEKA™, (bendamustine
hydrochloride) injection, a liquid, low-volume (50 mL) and short-time
10-minute infusion formulation of bendamustine. BENDEKA is approved for
the treatment of patients with chronic lymphocytic leukemia (CLL) and
for the treatment of patients with indolent B-cell non-Hodgkin lymphoma
(NHL) that has progressed during or within six months of treatment with
rituximab or a rituximab-containing regimen. Efficacy in CLL relative to
first-line therapies other than chlorambucil has not been established.
“We are thrilled that the FDA has approved BENDEKA and are excited for
what we believe will be a promising launch with Teva. Importantly, we
believe that patients with CLL or indolent B-cell NHL that has
progressed will benefit from the multiple administration options this
product offers,” said Scott Tarriff, President and Chief Executive
Officer of Eagle Pharmaceuticals.
“Teva looks forward to commercializing this new bendamustine product,
which we believe represents an important benefit to both patients and
healthcare providers,” said Paul Rittman, Senior Vice President and
General Manager, Teva Oncology. “We are pleased to add BENDEKA to Teva’s
Oncology portfolio, and bendamustine franchise, furthering our
commitment to enhancing treatment options for patients affected by
cancer.”
BENDEKA was granted Orphan Drug Designations for both CLL and indolent
B-cell NHL.
Under the February 2015 exclusive license agreement for BENDEKA, Teva is
responsible for all U.S. commercial activities for the product including
promotion and distribution. Teva expects to make BENDEKA commercially
available to prescribers during the first quarter of 2016.
Indications
BENDEKA is indicated for the treatment of patients with chronic
lymphocytic leukemia (CLL). Efficacy relative to first-line therapies
other than chlorambucil has not been established.
BENDEKA is indicated for the treatment of patients with indolent B-cell
non-Hodgkin lymphoma (NHL) that has progressed during or within six
months of treatment with rituximab or a rituximab-containing regimen.
Important Safety Information
Contraindication: BENDEKA is contraindicated in patients with a
known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions)
to bendamustine, polyethylene glycol 400, propylene glycol, or
monothioglycerol.
Myelosuppression: Bendamustine hydrochloride caused severe
myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies.
Three patients (2%) died from myelosuppression-related adverse
reactions. Monitor leukocytes, platelets, hemoglobin (Hgb), and
neutrophils frequently. Myelosuppression may require dose delays and/or
subsequent dose reductions if recovery to the recommended values has not
occurred by the first day of the next scheduled cycle.
Infections: Infection, including pneumonia, sepsis, septic shock,
hepatitis and death has occurred. Patients with myelosuppression
following treatment with BENDEKA are more susceptible to infections.
Patients treated with Bendamustine hydrochloride are at risk for
reactivation of infections including (but not limited to) hepatitis B,
cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients
should undergo appropriate monitoring, prophylaxis, and treatment
measures.
Anaphylaxis and Infusion Reactions: Infusion reactions to
bendamustine hydrochloride have occurred commonly in clinical trials.
Symptoms include fever, chills, pruritus, and rash. In rare instances
severe anaphylactic and anaphylactoid reactions have occurred,
particularly in the second and subsequent cycles of therapy. Monitor
clinically and discontinue drug for severe (Grade 3-4) reactions. Ask
patients about symptoms suggestive of infusion reactions after their
first cycle of therapy. Consider measures to prevent severe reactions,
including antihistamines, antipyretics, and corticosteroids in
subsequent cycles in patients who have experienced Grade 1 or 2 infusion
reactions.
Tumor Lysis Syndrome: Tumor lysis syndrome associated with
bendamustine hydrochloride has occurred. The onset tends to be within
the first treatment cycle with BENDEKA and, without intervention, may
lead to acute renal failure and death. Preventive measures include
vigorous hydration and close monitoring of blood chemistry, particularly
potassium and uric acid levels. There may be an increased risk of severe
skin toxicity when bendamustine hydrochloride and allopurinol are
administered concomitantly.
Skin Reactions: Skin reactions have been reported with
bendamustine hydrochloride treatment including rash, toxic skin
reactions, and bullous exanthema. In a study of bendamustine
hydrochloride (90 mg/m2) in combination with rituximab, one case of
toxic epidermal necrolysis (TEN) occurred. TEN has been reported for
rituximab. Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal,
have been reported when bendamustine hydrochloride was administered
concomitantly with allopurinol and other medications known to cause
these syndromes. Where skin reactions occur, they may be progressive and
increase in severity with further treatment. Monitor patients with skin
reactions closely. If skin reactions are severe or progressive, withhold
or discontinue BENDEKA.
Other Malignancies: There are reports of pre-malignant and
malignant diseases that have developed in patients who have been treated
with bendamustine hydrochloride, including myelodysplastic syndrome,
myeloproliferative disorders, acute myeloid leukemia, and bronchial
carcinoma. The association with BENDEKA therapy has not been determined.
Extravasation Injury: Extravasations resulting in
hospitalizations from erythema, marked swelling, and pain have been
reported with Bendamustine hydrochloride. Assure good venous access
prior to starting drug infusion and monitor the intravenous infusion
site for redness, swelling, pain, infection, and necrosis during and
after administration of BENDEKA.
Embryo-fetal Toxicity: Bendamustine hydrochloride can cause fetal
harm when administered to a pregnant woman. Women should be advised to
avoid becoming pregnant while using BENDEKA.
Most Common Adverse Reactions:
• Adverse reactions (frequency >5%) during infusion and within 24 hours
post-infusion are nausea and fatigue
• Most common non-hematologic adverse reactions for CLL (frequency ≥15%)
are pyrexia, nausea, and vomiting.
• Most common non-hematologic adverse reactions for NHL (frequency ≥15%)
are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation,
anorexia, cough, headache, weight decreased, dyspnea, rash, and
stomatitis.
• Most common hematologic abnormalities (frequency ≥15%) are
lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.
For BENDEKA Full Prescribing Information, please visit: http://www.bendeka.com/PrescribingInformation.PDF
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 molecules to
produce a wide range of generic products in nearly every therapeutic
area. In specialty medicines, Teva has a world-leading position in
innovative treatments for disorders of the central nervous system,
including pain, as well as a strong portfolio of respiratory products.
Teva integrates its generics and specialty capabilities in its global
research and development division to create new ways of addressing unmet
patient needs by combining drug development capabilities with devices,
services and technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on developing and
commercializing injectable products that address the shortcomings, as
identified by physicians, pharmacists and other stakeholders, of
existing commercially successful injectable products. Eagle’s strategy
is to utilize the FDA's 505(b)(2) regulatory pathway. Additional
information is available on the company’s website at www.eagleus.com.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our specialty products, especially Copaxone® (including
competition from orally-administered alternatives, as well as from
generic equivalents such as the recently launched Sandoz product) and
our ability to continue to migrate users to our 40 mg/mL version and
maintain patients on that version; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities (such as our pending acquisitions of Allergan’s generic
business and Rimsa), or to consummate and integrate acquisitions; the
possibility of material fines, penalties and other sanctions and other
adverse consequences arising out of our ongoing FCPA investigations and
related matters; our ability to achieve expected results from the
research and development efforts invested in our pipeline of specialty
and other products; our ability to reduce operating expenses to the
extent and during the timeframe intended by our cost reduction program;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and Europe of our patent
settlement agreements; our exposure to currency fluctuations and
restrictions as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the effects of
reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with internal
or third-party information technology systems that adversely affect our
complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
competition for our specialty pharmaceutical businesses from companies
with greater resources and capabilities; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; potentially significant increases in tax
liabilities; the effect on our overall effective tax rate of the
termination or expiration of governmental programs or tax benefits, or
of a change in our business; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2014 and in our other filings with the U.S. Securities and Exchange
Commission.
Eagle's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This press release contains forward-looking information within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended and other securities laws. Forward-looking statements are
statements that are not historical facts. Words such as “will,” “may,”
“intends,” “anticipate(s),” “plan,” “enables,” “potentially,”
“entitles,” and similar expressions are intended to identify
forward-looking statements. These statements include, but are not
limited to, statements regarding future events including, but not
limited to: ADD IN HERE; difficulties or delays in manufacturing; the
availability and pricing of third party sourced products and materials;
successful compliance with FDA and other governmental regulations
applicable to manufacturing facilities, products and/or businesses; and
other factors that are discussed in Eagle’s Annual Report on Form 10-K
for the year ended September 30, 2014, and its other filings with the
U.S. Securities and Exchange Commission. All of such statements are
subject to certain risks and uncertainties, many of which are difficult
to predict and generally beyond Eagle’s control, that could cause actual
results to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. Such risks
include, but are not limited to risks described in Eagle’s filings with
the U.S. Securities and Exchange Commission. Readers are cautioned not
to place undue reliance on these forward-looking statements that speak
only as of the date hereof, and we do not undertake any obligation to
revise and disseminate forward-looking statements to reflect events or
circumstances after the date hereof, or to reflect the occurrence of or
non-occurrence of any events.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151208005695/en/
Source: Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc.
Teva Pharmaceutical Industries Ltd.
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